Kornimate/medical-research-clean huggingface dataset:
hyperfractionated versus conventionally fractionated radiotherapy in standard risk medulloblastoma

Conditions: Medulloblastoma

Summary: this is an international prospective randomised trial, which will compare two radiotherapy regimens in children and adolescents (aged 4 or 5 years to 21 years inclusive) with carefully staged 'standard risk' medulloblastoma.

patients eligible for the study will be those with non-metastatic medulloblastoma (by imaging and csf cytology) at diagnosis. patients randomised to the standard arm will receive conventionally fractionated (once a day) radiotherapy with a dose of 54 gy to the posterior fossa and 23.4 gy to the craniospinal axis. the experimental arm will be hyperfractionated (twice a day) radiotherapy (1 gy b.d.) with a dose of 60 gy to the posterior fossa with an additional 8 gy to the tumour bed and 36 gy to the craniospinal axis. both groups will receive identical chemotherapy consisting of eight weekly doses of vincristine given with radiotherapy and 8 courses of ccnu, cisplatin and vincristine following radiotherapy.

Eligibility criteria:
inclusion criteria: * age at diagnosis at least 4 years or 5 years (according to the policy of the national brain tumour group) and less than 22 years. * histologically proven medulloblastoma, including the following variants(who classification - 2000): classic medulloblastoma, nodular / desmoplastic medulloblastoma, melanotic medulloblastoma, medullomyoblastoma no cns metastasis on mri - supratentorial, arachnoid of the posterior fossa or spine. * no clinical evidence of extra-cns metastasis * no tumour cells on the cytospin of lumbar csf. central review of csf cytology is recommended but not mandatory. it will be left to national policy. * radiotherapy to start no more than 40 days after surgery. * ability to receive twice daily radiotherapy. * vital functions within normal range for their age group. * ctc grades \< 2 for liver, renal, haematological and audiological function. * no medical contraindication to radiotherapy or chemotherapy. * written informed consent (and patient assent where appropriate) according to the laws of each participating country. written informed consent should also be sought for biological studies. * national and local ethical committee approval according to the laws of each participating country (to include approval for biological studies). exclusion criteria: * one of the inclusion criteria is lacking. * brainstem or supratentorial primitive neuroectodermal tumour. * atypical teratoid rhabdoid tumour. * medulloepithelioma. * ependymoblastoma. * large cell médulloblastoma. * metastatic medulloblastoma (on cns mri and/or positive cytospin of postoperative lumbar csf). * patient previously treated for a brain tumour or any type of malignant disease. * patients who are pregnant. * females who are sexually active and not taking reliable contraception. * known predisposition to medulloblastoma e.g. gorlin's syndrome.
feasibility study to evaluate renal denervation using focused ultrasound

Conditions: Hypertension

Summary: this study is a prospective, multi-center trial wherein each included subject will receive the experimental externally focused ultrasound renal denervation therapy. it will be conducted on a maximum of fifty patients who meet the inclusion and exclusion criteria and have signed the informed consent form. safety is the primary endpoint of this study and will be assessed by incidence and evaluation of any serious adverse effects associated with the investigational procedure through the 52-week evaluation. clinical utility is the secondary endpoint of this study and will be evaluated by assessing pre and post therapy systolic and diastolic blood pressure.


Eligibility criteria:
inclusion criteria: * subject is at least 18 years of age. * subject has systolic blood pressure of 160 mmhg in average or greater. * subject has refractory, stable hypertension despite being treated with at least three hypertensive drugs. * subject has two functioning kidneys, defined as egfr ≥ 45 ml/min. * subject has at least one renal artery on each side which is greater than 4mm. exclusion criteria: * subject has hydronephrosis as seen on mra or ultrasound. * subject has renal stenosis greater than 50% based on baseline mra. * subject has a renal stent or other implant in the region. * subject has kidney stones which are symptomatic and/or greater than 1cm or in the discretion of the investigator may interfere with treatment. * subject has a history of abdominal surgery within the past six months. * subject has heterogeneities in the kidney such as large cysts or tumors which in the discretion of the investigator may interfere with treatment. * subject has active pyelonephritis or a history of pyelonephritis which in the discretion of the investigator may interfere with treatment. * subject has a history of myocardial infarction, unstable angina pectoris, or cerebrovascular accident within the last six months. * subject has hemodynamically significant valvular heart disease. * subject has an implantable cardioverter defibrillator, pacemaker, neurostimulator or other device incompatible with mri. * subject has a body weight \> 150 kilograms. * subject has a target treatment depth \> 14 cm. * subject is pregnant, nursing or intends to become pregnant during the trial period. * subject is currently enrolled in other potentially confounding research. * subject has any condition that, at the discretion of the investigator, would preclude participation in the trial.
strength training as prevention and treatment of late effects in long-term survivors of pediatric hsct.

Conditions: Stem Cell Transplant; Late Effect; Metabolic Syndrome; Cardiovascular Diseases

Summary: today the overall survival of childhood cancers has increased to above 85%. this increase is partially caused by treatment with bone marrow transplantation. a bone marrow transplantation is an efficient treatment against high-risk leukemia, as well as other life-threatening immunological and hematological diseases. however, it is unfortunately also related to the risk of developing a long series of late effects during early adulthood, such as low muscle mass, cardiovascular disease and diabetes. conditions known from the older generations of the general population and also conditions highly related to lifestyle factors in the general population. in the group of survivors after bone marrow transplantation, the cause for these late effects is not fully understood, as the same close association to lifestyle factors as seen in the general population, is not present in this group. multiple studies have examined the possible causes, and it have been shown that certain elements of a bone marrow transplantation, ie. total body irradiation, are associated with the risk of developing late effects. as the cause is not fully understood, it is not known whether the treatment and preventive strategies, that would be applied in the general population for these conditions, are effective in this group. therefore, in this study the investigators aim at examining the effect of a strength training intervention on the development of the aforementioned late effects to treatment with bone marrow transplantation during childhood. the investigators will invite a group of persons, transplanted during childhood, as well as an age- and sex-matched control group to participate in the study. both groups will go through a 16-week strength training intervention, and a thorough health examination before and after the intervention, to assess metabolic status and body composition. if the investigators find a positive effect of strength training on muscle mass and risk factors for developing cardiovascular disease and diabetes in persons, treated with bone marrow transplantation during childhood, it will support the implementation of structured training programs in the follow-up of these patients. thereby hopefully contributing to an increased quality of life, as well as an increased life expectancy in the group of survivors after bone marrow transplantation during childhood.


Eligibility criteria:
inclusion criteria: * living in copenhagen, denmark or surrounding area - making it possible to engage in strength training 3 times a week at bispebjerg hospital, copenhagen, denmark. * ≥ 18 years old exclusion criteria: * illness or physical handicap making it impossible to participate in the training intervention * pregnancy * not danish or english speaking * anemia * already performing regular structured physical training * strict vegan or vegetarian diet * illness or ongoing treatment that hinders study examinations

Keywords: strength training resistance training
effect of extraction vs non-extraction orthodontic treatment on vertical facial dimension

Conditions: Malocclusion; Long Face Syndrome; Crowding, Tooth

Summary: the aim of the current clinical trial was to evaluate the effects of premolar extractions compared with non-extraction orthodontic treatment on the skeletal vertical dimension of the face. the null-hypothesis is that there is no difference in post-treatment skeletal vertical characteristics of normodivergent and hyperdivergent patients treated orthodontically with first premolar extractions compared with patients treated in non-extraction manner.

the current protocol will be submitted for partial fulfillment of the phd requirements in faculty of dentistry, cairo university. the trial will be conducted in the outpatient clinic of the orthodontic department, faculty of dentistry, cairo university. primary examination and diagnosis of the patients seeking orthodontic treatment will be performed, to select a sample of the trial. then, final diagnosis and planing of each participant will be performed by a trained orthodontists to be sure that all patients fallen with the inclusion criteria. interventions will be conducted with the same orthodontist, under supervision of orthodontic professors in the orthodontic department, cairo university.

Eligibility criteria:
inclusion criteria: * normodivergent and hyperdivergent patients * cases with moderate crowding. * borderline cases which could be treated with extraction or non-extraction strategies exclusion criteria: * hypodivergent patients. * cases with extremely sever crowding. * patients with high caries index or periodontal problems. * patients with systemic diseases, or syndromic conditions.

Keywords: orthodontics vertical dimension premolars extraction long face
ursodeoxycholic acid combined with total glucosides of paeony in the treatment of pbc with aih features 1

Conditions: Hepatitis; Primary Biliary Cholangitis; Autoimmune

Summary: a randomized controlled open-label clinical trial of ursodeoxycholic acid combined with total glucosides of paeony in the treatment of pbc with aih features 1


Eligibility criteria:
inclusion criteria: 1. patients aged 18-75 years; 2. the diagnosis of pbc is clear and does not meet the paris criteria for diagnosing pbc overlap aih, but it needs to meet 1.0xuln \< alt ≤ 3.0xuln or 1.0xuln \< ast ≤ 3.0xuln or 1.0xuln \< igg ≤ 1.3xuln, and liver pathological biopsy excludes moderate or higher interface inflammation; 3. agreed to participate in the trial, and assigned informed consent. exclusion criteria: 1. the presence of hepatitis a, b, c, d, or e virus infection; 2. patients with presence of cirrhosis; 3. patients with presence of fulminant liver failure; 4. liver damage caused by other reasons: such as primary sclerosing cholangitis, non-alcoholic steatohepatitis, drug induced liver disease or wilson's disease; 5. pregnant and breeding women and women of childbearing age in need of reproduction; 6. severe disorders of other vital organs, such as severe heart failure, cancer; 7. parenteral administration of blood or blood products within 6 months before screening; 8. recent treatment with drugs having known liver toxicity; 9. taken part in other clinic trials within 6 months before enrollment.
hearing aids with "notched amplification" for the treatment of chronic tinnitus

Conditions: Tinnitus

Summary: pilot study on safety, tolerability and clinical performance/randomized double-blind active-controlled pilot-study. patients are being recruited from patients of the tinnitus center of regensburg and groupwise randomized. control groups are being treated with hearing aids without notch-filter. patients and raters are blinded, only the coworker, who is programming the hearing aids, is informed about the group assigned. a hearing aid with notched amplification filters frequencies in a specific manner, depending on the individual tinnitus frequency. through this special filtering the neuronal functional changes of the auditory cortex are supposed to be affected therapeutically.


Eligibility criteria:
inclusion criteria: * chronic tinnitus (≥ 6 months) * score of ≥ 10 in tq12 (goebel und hiller) * mild to moderate hearing loss of at least 20 db and maximum 70 db between 250 hz and 8 khz * tinnitus with tonal character or narrow band noise (\< 1 oktave bandwidth) * tinnitus frequency ≤ 8 khz in tinnitus matching * written informed consent of the proband * if therapy with psychoactive substances is necessary, it has to be stable during at least 10 days and should remain constant during study (changes will be documented in the crf) * no regular use (8 hours daily) of hearing aids during 3 month before start of study exclusion criteria: * objective tinnitus * start of other tinnitus therapies during 3 months before start of study. * missing written consent * clinically relevant serious internal, neurologic or psychiatric diseases * abuse of drugs, medicaments and alcohol up to 12 weeks before start of study * other circumstances that object to study inclusion according to the opinion of the investigator
analgesia in the second stage of labour

Conditions: Childbirth Experience; Urinary Retention; Satisfaction, Personal; Pain, Obstetric

Summary: this study investigates efficacy, safety and childbirth experience in women receiving pudendal block during the final stage of delivery. it is an observational study and half of included primarous women recieve a pudendal block.

pudendal block is used when there is a need to alleviate pain in the final stage of labour: * from fully dilated cervix to delivery of the child. * associated with pain as the foetus rotates and descends through the pelvis. * end of second stage: the perineum dilates as the child is being born. pudendal block is provided by inserting a needle close to the pudendal nerve that runs through the pelvis and innervates the perineal area.pudendal block is an old and relatively simple method, but not well studied. the main aim is to study pudendal nerve block as pain relief in final stage of labour for primiparous women delivering vaginally. the investigators aim to investigate whether possible adverse effects may outweigh the positive analgesic effect in the final stage of labour, or the opposite. the asl (analgesia in the second stage of labour) study may fill knowledge gaps and add important knowledge regarding pain relief during the final stage of childbirth.

Eligibility criteria:
inclusion criteria: * norwegian-speaking/reading * primiparity * single pregnancy * vaginal birth * cephalic presentation * ≥37+0 * age ≥18 years exclusion criteria: * transferre from midwifery-led birth unit * allergy to local anaesthesia * not valid data on pudendal block

Keywords: pudendal nerve block urine and urination anesthetics peripheral nervous system agents
real-world effectiveness of combination therapies in primary care asthma management

Conditions: Asthma

Summary: to evaluate whether beclomethasone dipropionate / formoterol (bdp/for; fostair® 100/6) is at least equivalent in terms of exacerbation prevention to fluticasone dipropionate / salmeterol (fp/sal; seretide® 125) in matched asthma patients switching to bdp/for following treatment with fp/sal in normal clinical practice compared with patients not switched.

to evaluate whether beclomethasone dipropionate / formoterol (bdp/for; fostair® 100/6) is at least equivalent in terms of exacerbation prevention to fluticasone dipropionate / salmeterol (fp/sal; seretide®) in matched asthma patients switching to bdp/for following treatment with fp/sal in normal clinical practice compared with patients not switched. to evaluate respiratory outcomes for fostair in comparison to seretide using a uk primary care database (in patients switched for cost rather than clinical reasons).

Eligibility criteria:
inclusion criteria: * aged: 18-80 years 61-80 years to be non-smokers only * evidence of asthma: a diagnostic code for asthma or two scripts for asthma.. * baseline fp/sal therapy: ≥2 prescription for ics/laba therapy as fp/sal * evidence of continuing therapy: include only patients who receive ≥2 prescriptions for the therapy under study during the outcome year (i.e. ≥1 prescription at the index date and ≥1 other). uk average is 3-4 prescriptions refilled per year, so ≥2 ensures capture of "real-life" data. * evidence of switching for economic reasons: fp/sal patients from practices with ≥5 switches to fostair in a 3 month period to minimise data taken from switching of anomalous patients; optimal practices for inclusion are those switching "wholesale" for economic reasons. exclusion criteria: * any chronic respiratory disease other than asthma * are receiving maintenance oral steroid therapy during baseline period

Keywords: primary care asthma management real-world observational fostair seretide
factors associated to the instability of the inr (international normalized ratio ) in the prevention of thromboembolism avk (anti vitamin k) in atrial fibrillation in the elderly: instead of comorbidities

Conditions: Atrial Fibrillation

Summary: atrial fibrillation (af) is a common condition whose prevalence increases with advancing age . one of the main complications of this arrhythmia is the occurrence of systemic thromboembolism, the first of which the occurrence of cerebrovascular accident (cva) . the advanced age itself is an independent risk factor for occurrence of stroke in the context of af , evidenced by the score awarded to the age over 75 years in the risk estimate thromboembolism in the score cha2ds2-vasc . making the elderly a priority target for the prevention of thromboembolism, both because of the increased thromboembolic risk and prevalence of af in this population. for many years, vitamin k antagonists (vka) have proven their effectiveness in this context . but the effectiveness and safety of thromboembolism prevention by anti-vitamin k treatment involves maintaining the inr (international normalized ratio) in the therapeutic range. indeed occurred of a thromboembolic or haemorrhagic adverse event directly correlates to having an inr outside the therapeutic range and maintaining the inr in the therapeutic range is subject to many variations inter- and intra-individual. they include, genetic factors , food , drug interactions , as well as disease processes . or one of the elderly characteristics is the coexistence of multiple pathological processes or comorbidities . the supposed interaction between comorbidities and variability of inr has been little studied: only a few studies have examined the factors associated with the stability of the inr and unstable . the identification of patients at risk of instability inr yet allow clinicians greater vigilance and better identification of patients for whom the initiation of treatment with vitamin k does not appear the best therapeutic strategy. our study seeks to determine whether comorbidity, assessed by the charlson comorbidity index, are associated with instability of the inr, among more than 80 years for patients treated with avk atrial fibrillation.


Eligibility criteria:
inclusion criteria: * patients aged 80 years or more; * patients present in geriatric structure june 21, 2011 ( short geriatric , ssr , ltc or nursing homes ) ; * patients with avk june 21, 2011 or having received warfarin in the previous 7 days ; * patients with avk under thromboembolism prevention in atrial fibrillation . exclusion criteria: * - patients receiving avk for another reason thromboembolism prevention for atrial fibrillation : treatment of venous thromboembolism , pulmonary embolism, mechanical heart valve , etc

Keywords: atrial fibrillation , comorbidities
remote ischemic conditioning in septic shock

Conditions: Septic Shock

Summary: septic shock remains a major public health problem in industrialized countries, with a mortality rate as high as 50%, largely related to multiple organ dysfunction. in addition to dysregulated inflammatory response, the pathophysiology of organ failures in septic shock involves ischemia-reperfusion processes. remote ischemic conditioning is a therapeutic strategy for protecting organs against the detrimental effects of ischemia-reperfusion injury. the objective of the present study is to determine whether remote ischemic conditioning can limit the severity of organ failure in patients with septic shock.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * hospitalization in an intensive care unit for less than 24 hours * septic shock evolving for less than 12 hours defined as: * documented or suspected infection * norepinephrine administration to maintain a mean arterial pressure ≥ 65 mmhg after volemia correction * lactatemia \> 2 mmol/l at least once in the past 12 hours before inclusion * written informed consent signed by the patient or by a next of kin or oral consent given by the patient and as soon as permitted by the clinical state written informed consent signed by the patient. exclusion criteria: * patient who has expressed the wish not to be resuscitated * contraindication of the use of brachial cuff on both arms * intercurrent pathology with an expected life expectancy of less than 24 hours * cardiac arrest * female patients currently pregnant or women of childbearing age who are not using contraception * previous inclusion in reco-sepsis study * previous inclusion in another clinical study * patients without health coverage

Keywords: intensive care septic shock multiple organ failure ischemia-reperfusion ischemic conditioning remote conditioning sofa score
a study to evaluate the safety and tolerability of bms-986408 alone and in combination with nivolumab or nivolumab and ipilimumab in participants with advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: the primary purpose of this study is to characterize the safety profile of bms-986408 as monotherapy and in combination with nivolumab or nivolumab and ipilimumab to establish the maximum tolerated dose (mtd). the recommended phase 2 dose (rp2d) that optimizes the pharmacokinetic/pharmacodynamic (pk/pd) relationship of bms-986408 will also be determined.


Eligibility criteria:
inclusion criteria: * participants with a histologically or cytologically confirmed, advanced, unresectable/metastatic, solid malignancy of any histology measurable by response evaluation criteria in solid tumors (recist) v1.1 * participants who have received, been refractory to, ineligible for, or intolerant of existing therapy(ies) known to provide clinical benefit for the condition of the participant * participants with melanoma should have documentation of mutation status for b-type raf proto-oncogene (braf) and neuroblastoma ras viral oncogene homolog (nras) * participants must have experienced radiographically documented progressive disease on or after the most recent therapy exclusion criteria: * an active, known or suspected autoimmune disease * conditions requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment * current or recent gastrointestinal disease or gastrointestinal surgery that could impact the absorption of study drug * untreated central nervous system (cns) metastases or leptomeningeal metastasis other protocol-defined inclusion/exclusion criteria apply

Keywords: cancer oncology phase 1 solid tumor